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Trial Title:
Clinical Value of Breast High-Resolution MR Ductography in Patients With Pathological Nipple Discharge
NCT ID:
NCT05812040
Condition:
Breast Neoplasms
Nipple Discharge
Conditions: Official terms:
Breast Neoplasms
Galactorrhea
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Magnetic Resonance Ductography (MRD); and High-Resolution Magnetic Resonance Ductography (HR-MRD)
Description:
all participants will receive Magnetic Resonance Ductography (MRD) and High-Resolution
Magnetic Resonance Ductography (HR-MRD) examination, using breast dedicated coil and
microscopic coil, respectively
Arm group label:
MRD + HR-MRD
Summary:
Nipple discharge is one of the common symptoms of breast disease patients. Nipple
discharge can be divided into physiological and pathological nipple discharge (PND).
Among patients with PND symptoms who undergo biopsy, 5%-21% of them are malignant, and
the risk of malignancy increases with age. The primary diagnostic imaging methods for PND
patients include mammography and breast ultrasound. Nearly half of PND patients who
undergo traditional mammography and ultrasound examination have negative findings, but
this does not rule out the presence of malignant lesions. Central duct excision is the
gold standard for PND diagnosis, but invasive surgery without imaging guidance can lead
to some complications. Magnetic Resonance Ductography (MRD), which uses water imaging
technology to visualize the inside of the duct without contrast injection, can show
imaging features of ductal lesions such as filling defects, irregularities of duct walls,
and ductal obstruction. However, previous studies have shown that the signal-to-noise
ratio of MRD images needs to be improved. Microscopy coil has the characteristics of
small voxels and high spatial resolution, making it suitable for high signal-to-noise
ratio imaging of small superficial structures. This provides a hardware foundation for
improving the quality of MRD images. Therefore, in this study, the investigators aim to
use the 3T MR instrument and microscopy coil to perform non-invasive high-resolution
Magnetic Resonance Ductography (HR-MRD) on PND patients to evaluate the ability of HR-MRD
to detect PND causes and the imaging features of duct-related lesions on HR-MRD, to
assist in the accurate diagnosis and treatment of PND.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Female patients aged between 18 and 75 years old.
- Pathological nipple discharge patients who received treatment at Sun Yat-sen
Memorial Hospital. The diagnostic criteria for pathological nipple discharge include
unilateral, single duct orifice, and spontaneous discharge of serous or bloody
fluid. Patients who meet any of the above criteria are considered as pathological
discharge.
- Willing to sign an informed consent form for clinical research and undergo HR-MRD
and MRD examination.
Exclusion Criteria:
- Patients who have undergone surgery on the nipple-areolar complex of the PND breast
side within the past year.
- Patients who have claustrophobia or metal implants in their body, which are not
suitable for MRI scans.
- Patients who are pregnant or breastfeeding.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Recruiting
Contact:
Last name:
Yue Hu, MD.
Phone:
+86 13760765813
Email:
huyue57@mail.sysu.edu.cn
Start date:
March 2, 2023
Completion date:
May 30, 2024
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05812040
